WO1998034630A1 - Use of gastrointestinal lipase inhibitors - Google Patents

Use of gastrointestinal lipase inhibitors Download PDF

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Publication number
WO1998034630A1
WO1998034630A1 PCT/EP1998/000468 EP9800468W WO9834630A1 WO 1998034630 A1 WO1998034630 A1 WO 1998034630A1 EP 9800468 W EP9800468 W EP 9800468W WO 9834630 A1 WO9834630 A1 WO 9834630A1
Authority
WO
WIPO (PCT)
Prior art keywords
tetrahydrolipstatin
gastrointestinal lipase
diabetes mellitus
lipase inhibitor
oral
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP1998/000468
Other languages
English (en)
French (fr)
Inventor
Jonathan Brian Hauptman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
F Hoffmann La Roche AG
Original Assignee
F Hoffmann La Roche AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=21894047&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO1998034630(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to PL334975A priority Critical patent/PL191222B1/pl
Priority to CA2278854A priority patent/CA2278854C/en
Priority to AT98908008T priority patent/ATE292975T1/de
Priority to HK00104500.5A priority patent/HK1025251B/xx
Priority to HU0001014A priority patent/HU230834B1/hu
Priority to AU66169/98A priority patent/AU740375B2/en
Priority to KR10-1999-7006983A priority patent/KR100479968B1/ko
Priority to DE69829763T priority patent/DE69829763T2/de
Application filed by F Hoffmann La Roche AG filed Critical F Hoffmann La Roche AG
Priority to JP53371598A priority patent/JP2001509173A/ja
Priority to EP98908008A priority patent/EP1017408B1/en
Priority to BR9807655-8A priority patent/BR9807655A/pt
Priority to MEP-903/08A priority patent/ME00578A/xx
Priority to DK98908008T priority patent/DK1017408T3/da
Priority to IL13100798A priority patent/IL131007A0/xx
Priority to NZ336755A priority patent/NZ336755A/en
Publication of WO1998034630A1 publication Critical patent/WO1998034630A1/en
Priority to NO19993717A priority patent/NO324452B1/no
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics

Definitions

  • Diabetes mellitus is a condition characterized by an abnormality of glucose utilization and associated with elevation of blood glucose concentration.
  • the most common form of diabetes mellitus is non-insulin dependent diabetes mellitus
  • NIDDM Type II diabetes mellitus
  • Type II diabetes mellitus Over 10 million people in the United States alone are affected with type II diabetes mellitus. The initial approach in treating obese patients affected with type II diabetes mellitus is weight reduction. Other types of treatment include oral hypoglycemics and insulin. See, Gregerman, MD, Section 10, Metabolic and Endocrinological Problems, Chapter 72, Diabetes Mellitus, pages 977-989.
  • the invention relates to the use of a gastrointestinal lipase inhibitor for the manufacture of oral medicaments for treating or preventing type II diabetes mellitus.
  • the invention relates to an oral medicament for treating or preventing type II diabetes mellitus characterized in that it contains a gastrointestinal lipase inhibitor.
  • the gastrointestinal lipase inhibitor is preferably tetrahydrolipstatin.
  • Tetrahydrolipstatin also known as orlistat, is a known compound useful for the control or prevention of obesity and hyperlipidemia. See, U.S. Patent No. 4,598,089, issued July 1, 1986, which also discloses processes for making tetrahydrolipstatin.
  • a gastrointestinal lipase inhibitor when administered orally is useful in the treatment and prevention of type II diabetes mellitus.
  • a gastrointestinal lipase inhibitor preferably tetrahydrolipstatin
  • a gastrointestinal lipase inhibitor when administered orally is useful in the treatment and prevention of type II diabetes mellitus.
  • a gastrointestinal lipase inhibitor preferably tetrahydrolipstatin
  • from 60 to 720 mg per day of the gastrointestinal lipase inhibitor are orally administered in divided doses two to three times per day.
  • a gastrointestinal lipase inhibitor is administered to a subject, preferably in divided doses two or, particularly, three times per day.
  • the subject is preferably an obese or overweight human, i.e. a human with a body mass index of 25 or greater.
  • the gastrointestinal lipase inhibitor be administered within about one or two hours of ingestion of a meal containing fat.
  • treatment be administered to 1 ) a human who has a strong family history of type II diabetes mellitus and has obtained a body mass index of 25 or greater; or 2) a human with impaired glucose tolerance who has obtained a body mass index of 25 or greater.
  • the term crizstrong family history means a human with at least one first degree relative who has type II diabetes mellitus.
  • impaired glucose tolerance would be diagnosed by an oral glucose tolerance test.
  • Tetrahydrolipstatin can be administered to humans in conventional oral compositions, such as, tablets, coated tablets, hard and soft gelatin capsules, emulsions or suspensions.
  • carriers which can be used for tablets, coated tablets, dragees and hard gelatin capsules are lactose, maize starch or derivatives thereof, talc, stearic acid or its salts and the like.
  • Suitable carriers for soft gelatin capsules are, for example, vegetable oils, waxes, fats, semi-solid and liquid polyols and the like.
  • the pharmaceutical preparations can contain preserving agents, solubilizers, stabilizing agents, wetting agents, emulsifying agents, sweetening agents, coloring agents, flavoring agents, salts for varying the osmotic pressure, buffers, coating agents or antioxidants. They can also contain still other therapeutically valuable substances.
  • the formulations may conveniently be presented in unit dosage form and may be prepared by any methods known in the pharmaceutical art.
  • tetrahydrolipstatin is administered according to the formulation of Example 1.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Obesity (AREA)
  • Emergency Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Immunology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
  • Medicines Containing Plant Substances (AREA)
PCT/EP1998/000468 1997-02-05 1998-01-29 Use of gastrointestinal lipase inhibitors Ceased WO1998034630A1 (en)

Priority Applications (16)

Application Number Priority Date Filing Date Title
NZ336755A NZ336755A (en) 1997-02-05 1998-01-29 Use of gastrointestinal lipase inhibitors in particular tetrahydrolipstatin (orlistat)
CA2278854A CA2278854C (en) 1997-02-05 1998-01-29 Use of the gastrointestinal lipase inhibitor tetrahydrolipstatin for treating type ii diabetes
AT98908008T ATE292975T1 (de) 1997-02-05 1998-01-29 Verwendung von tetrahydolipstatin in der behandlung von diabetes typ ii
HK00104500.5A HK1025251B (en) 1997-02-05 1998-01-29 Use of gastrointestinal lipase inhibitors
HU0001014A HU230834B1 (hu) 1997-02-05 1998-01-29 Tetrahidrolipsztatin felhasználása
AU66169/98A AU740375B2 (en) 1997-02-05 1998-01-29 Use of gastrointestinal lipase inhibitors
KR10-1999-7006983A KR100479968B1 (ko) 1997-02-05 1998-01-29 위장 리파아제 억제제의 용도
DE69829763T DE69829763T2 (de) 1997-02-05 1998-01-29 Verwendung von tetrahydolipstatin in der behandlung von diabetes typ ii
JP53371598A JP2001509173A (ja) 1997-02-05 1998-01-29 胃腸リパーゼ阻害剤の使用
PL334975A PL191222B1 (pl) 1997-02-05 1998-01-29 Zastosowanie tetrahydrolipstatyny do wytwarzania doustnego farmaceutycznego preparatu do leczenia cukrzycy typu II
MEP-903/08A ME00578A (en) 1997-02-05 1998-01-29 Use of gastrointestinal lipase inhibitors
BR9807655-8A BR9807655A (pt) 1997-02-05 1998-01-29 Uso de inibidores de lipase gastrintestinal.
EP98908008A EP1017408B1 (en) 1997-02-05 1998-01-29 Use of tethrahydrolipstatin in the treatment of diabetes type ii
DK98908008T DK1017408T3 (da) 1997-02-05 1998-01-29 Anvendelse af tetrahydrolipstatin i behandling af diabetes type II
IL13100798A IL131007A0 (en) 1997-02-05 1998-01-29 Use of gastrointestinal lipase inhibitors
NO19993717A NO324452B1 (no) 1997-02-05 1999-07-30 Anvendelse av tetrahydrolipstatin til fremstilling av medikamenter mot diabetes

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US3738397P 1997-02-05 1997-02-05
US60/037,383 1997-02-05

Publications (1)

Publication Number Publication Date
WO1998034630A1 true WO1998034630A1 (en) 1998-08-13

Family

ID=21894047

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1998/000468 Ceased WO1998034630A1 (en) 1997-02-05 1998-01-29 Use of gastrointestinal lipase inhibitors

Country Status (27)

Country Link
US (1) US6147108A (cs)
EP (1) EP1017408B1 (cs)
JP (1) JP2001509173A (cs)
KR (1) KR100479968B1 (cs)
CN (1) CN1154505C (cs)
AR (1) AR011106A1 (cs)
AT (1) ATE292975T1 (cs)
AU (1) AU740375B2 (cs)
BR (1) BR9807655A (cs)
CA (1) CA2278854C (cs)
CZ (1) CZ295567B6 (cs)
DE (1) DE69829763T2 (cs)
DK (1) DK1017408T3 (cs)
ES (1) ES2239799T3 (cs)
HU (1) HU230834B1 (cs)
ID (1) ID22650A (cs)
IL (1) IL131007A0 (cs)
ME (1) ME00578A (cs)
NO (1) NO324452B1 (cs)
NZ (1) NZ336755A (cs)
PL (1) PL191222B1 (cs)
PT (1) PT1017408E (cs)
RU (1) RU2201272C2 (cs)
TR (1) TR199901853T2 (cs)
WO (1) WO1998034630A1 (cs)
YU (1) YU34199A (cs)
ZA (1) ZA98753B (cs)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6147108A (en) * 1997-02-05 2000-11-14 Hoffman-La Roche Inc. Method for treating type II diabetes mellitus
WO2001019340A1 (en) * 1999-09-13 2001-03-22 F. Hoffmann-La Roche Ag Dispersion formulations containing lipase inhibitors
EP1134231A1 (en) 2000-03-14 2001-09-19 Unilever N.V. Antibody heavy chain variable domains against human dietary enzymes, and their uses
US6703369B1 (en) 1999-09-13 2004-03-09 Hoffman-La Roche Inc. Lipase inhibiting compositions
WO2009050720A1 (en) * 2007-10-15 2009-04-23 Inventis Dds Pvt Limited Pharmaceutical composition of orlistat

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7060675B2 (en) 2001-02-15 2006-06-13 Nobex Corporation Methods of treating diabetes mellitus
US6867183B2 (en) 2001-02-15 2005-03-15 Nobex Corporation Pharmaceutical compositions of insulin drug-oligomer conjugates and methods of treating diseases therewith
US6828297B2 (en) * 2001-06-04 2004-12-07 Nobex Corporation Mixtures of insulin drug-oligomer conjugates comprising polyalkylene glycol, uses thereof, and methods of making same
US7196059B2 (en) 2001-09-07 2007-03-27 Biocon Limited Pharmaceutical compositions of insulin drug-oligomer conjugates and methods of treating diseases therewith
US7053080B2 (en) * 2001-09-21 2006-05-30 Schering Corporation Methods and therapeutic combinations for the treatment of obesity using sterol absorption inhibitors
WO2003105768A2 (en) 2002-06-13 2003-12-24 Nobex Corporation Methods of reducing hypoglycemic episodes in the treatment of diabetes mellitus
US9174176B2 (en) * 2003-01-09 2015-11-03 Disperse Systems, Inc. Ultrasonic dispersion apparatus, system, and method
RU2248793C1 (ru) * 2003-11-13 2005-03-27 Лазебник Леонид Борисович Способ лечения стеатогепатитов
US7510849B2 (en) * 2004-01-29 2009-03-31 Glucolight Corporation OCT based method for diagnosis and therapy
EP1773878B1 (en) 2004-07-19 2015-03-04 Biocon Limited Insulin-oligomer conjugates, formulations and uses thereof
US7254429B2 (en) * 2004-08-11 2007-08-07 Glucolight Corporation Method and apparatus for monitoring glucose levels in a biological tissue
US8036727B2 (en) 2004-08-11 2011-10-11 Glt Acquisition Corp. Methods for noninvasively measuring analyte levels in a subject
AU2006235535A1 (en) 2005-04-13 2006-10-19 Glt Acquisition Corp. Method for data reduction and calibration of an OCT-based blood glucose monitor
US8217025B2 (en) * 2006-11-17 2012-07-10 Harbor Therapeutics, Inc. Drug screening and treatment methods
DE602007008567D1 (de) * 2007-09-12 2010-09-30 Mader S R L Pharmazeutische Zusammensetzungen zur oralen Verabreichung bei der Behandlung von Adipositas-Patienten
UA114700C2 (uk) 2007-10-16 2017-07-25 Біокон Лімітед Тверда фармацевтична форма для перорального застосування та процес її виготовлення
WO2009111542A2 (en) 2008-03-04 2009-09-11 Glucolight Corporation Methods and systems for analyte level estimation in optical coherence tomography
WO2010042499A1 (en) * 2008-10-06 2010-04-15 Banner Pharmacaps, Inc. Stable solutions of orlistat for pharmaceutical dosage forms
FR3017536B1 (fr) * 2014-02-18 2017-05-26 Univ La Rochelle Compositions pour la prevention et/ou le traitement de pathologies liees a l'alpha-glucosidase
JP2019515654A (ja) * 2016-03-16 2019-06-13 ザ ジェイ． デヴィッド グラッドストーン インスティテューツ 肥満及び／又は糖尿病を処置するための方法及び組成物、並びに候補処置薬剤を識別するための方法及び組成物
WO2019018849A1 (en) * 2017-07-21 2019-01-24 Kieu Hoang STATINES (ATORVASTATIN) THAT CAN REDUCE GLYCEMIA LEVEL IN DIABETICS

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Publication number Priority date Publication date Assignee Title
EP0638317A1 (de) * 1993-08-05 1995-02-15 F. Hoffmann-La Roche Ag Pharmazeutisches Präparat
US5540917A (en) * 1992-06-24 1996-07-30 Hoffmann-La Roche Inc. Biomass lipase inhibitor useful for treating adiposity
JPH09227398A (ja) * 1996-02-20 1997-09-02 Zeria Pharmaceut Co Ltd 抗肥満剤

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BR9807655A (pt) * 1997-02-05 2000-02-15 Hoffmann La Roche Uso de inibidores de lipase gastrintestinal.
US6004996A (en) * 1997-02-05 1999-12-21 Hoffman-La Roche Inc. Tetrahydrolipstatin containing compositions

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US5540917A (en) * 1992-06-24 1996-07-30 Hoffmann-La Roche Inc. Biomass lipase inhibitor useful for treating adiposity
EP0638317A1 (de) * 1993-08-05 1995-02-15 F. Hoffmann-La Roche Ag Pharmazeutisches Präparat
JPH09227398A (ja) * 1996-02-20 1997-09-02 Zeria Pharmaceut Co Ltd 抗肥満剤

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Cited By (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6147108A (en) * 1997-02-05 2000-11-14 Hoffman-La Roche Inc. Method for treating type II diabetes mellitus
WO2001019340A1 (en) * 1999-09-13 2001-03-22 F. Hoffmann-La Roche Ag Dispersion formulations containing lipase inhibitors
AU769415B2 (en) * 1999-09-13 2004-01-29 Cheplapharm Arzneimittel Gmbh Dispersion formulations containing lipase inhibitors
US6703369B1 (en) 1999-09-13 2004-03-09 Hoffman-La Roche Inc. Lipase inhibiting compositions
RU2239428C2 (ru) * 1999-09-13 2004-11-10 Ф.Хоффманн-Ля Рош Аг Дисперсионные композиции, содержащие ингибиторы липаз
CZ301901B6 (cs) * 1999-09-13 2010-07-28 F. Hoffmann-La Roche Ag Farmaceutická kompozice obsahující inhibitor lipázy, zpusob její prípravy a použití
HRP20020205B1 (hr) * 1999-09-13 2011-06-30 F. Hoffmann - La Roche Ag Disperzijske formulacije koje sadrže inhibitore lipaze
US8012494B2 (en) 1999-09-13 2011-09-06 Hoffmann-La Roche Inc. Pharmaceutical compositions containing lipase inhibitors
EP1134231A1 (en) 2000-03-14 2001-09-19 Unilever N.V. Antibody heavy chain variable domains against human dietary enzymes, and their uses
US7361741B2 (en) 2000-03-14 2008-04-22 Lipton, Division Of Conopco, Inc. Antibody, or fragment thereof, capable of binding specifically to human pancreatic lipase
WO2009050720A1 (en) * 2007-10-15 2009-04-23 Inventis Dds Pvt Limited Pharmaceutical composition of orlistat

Also Published As

Publication number Publication date
IL131007A0 (en) 2001-01-28
CN1154505C (zh) 2004-06-23
HUP0001014A2 (hu) 2000-08-28
DK1017408T3 (da) 2005-08-01
NO993717L (no) 1999-10-04
CZ265199A3 (cs) 2000-02-16
NO324452B1 (no) 2007-10-22
PT1017408E (pt) 2005-07-29
CZ295567B6 (cs) 2005-08-17
AU740375B2 (en) 2001-11-01
DE69829763D1 (de) 2005-05-19
YU34199A (sh) 2002-08-12
ZA98753B (en) 1998-08-05
CA2278854C (en) 2014-03-04
DE69829763T2 (de) 2006-04-13
BR9807655A (pt) 2000-02-15
ATE292975T1 (de) 2005-04-15
NZ336755A (en) 2001-06-29
HU230834B1 (hu) 2018-07-30
KR20000070733A (ko) 2000-11-25
ID22650A (id) 1999-12-02
CN1246798A (zh) 2000-03-08
CA2278854A1 (en) 1998-08-13
PL334975A1 (en) 2000-03-27
AU6616998A (en) 1998-08-26
ME00578A (en) 2011-12-20
JP2001509173A (ja) 2001-07-10
KR100479968B1 (ko) 2005-03-30
NO993717D0 (no) 1999-07-30
EP1017408B1 (en) 2005-04-13
PL191222B1 (pl) 2006-03-31
TR199901853T2 (xx) 1999-12-21
AR011106A1 (es) 2000-08-02
HUP0001014A3 (en) 2000-12-28
EP1017408A1 (en) 2000-07-12
HK1025251A1 (en) 2000-11-10
ES2239799T3 (es) 2005-10-01
US6147108A (en) 2000-11-14
RU2201272C2 (ru) 2003-03-27

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